FDA Begins to Implement New Re-inspection Fees

As of October 1, 2011, the USFDA began implementation of collecting fees for re-inspection and for non-compliance with recall orders. USFDA recognizes the particular complexities involved in the re-inspection of imported products. They are evaluating comments received in response to the Federal Register notice establishing fee rates for Fiscal Year 2012. FDA is not in a position to assess import re-inspection fees until the agency has resolved these issues and the agency notifies the public.

However, the FDA does intend to assess facility re-inspection fees in circumstances where the initial facility inspection begins on or after October 1, 2011. It will also assess fees for not complying with a recall order.

The FDA recommends that all firms assess their compliance with all statutory and regulatory requirements.